The test approved by the U.S. Food and Drug Administration for assessment of the barrier quality of medical exam gloves includes visual inspection and a water leak test. Neither method tests directly the ability of gloves to prevent penetration by microorganisms. Methods that use microorganisms (viruses and bacteria) to test gloves have been developed but require classical culturing of the organism to detect it. We have developed a PCR assay for bacteriophage φX174 that allows the rapid detection of penetration of gloves by this virus. The method is suitable for use with both latex and synthetic gloves. The presence of glove powder on either latex or synthetic gloves had no effect on the ability of the PCR assay to detect bacteriophage DNA. The assay is rapid, sensitive, and inexpensive; requires only small sample volumes; and can be automated.
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机译:美国食品药品监督管理局(US Food and Drug Administration)批准的用于评估医用检查手套的阻隔质量的测试包括外观检查和漏水测试。两种方法都不能直接测试手套防止微生物渗透的能力。已经开发了使用微生物(病毒和细菌)来测试手套的方法,但是需要经典的培养方法来检测手套。我们已经开发了一种用于噬菌体φX174的PCR检测方法,可以快速检测这种病毒对手套的渗透。该方法适用于乳胶手套和合成手套。乳胶手套或合成手套上的手套粉的存在对PCR检测噬菌体DNA的能力没有影响。该测定快速,灵敏且便宜。只需要少量样品;并且可以自动化。
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